Active Ingredient and Strength	FULVESTRANT - 50 MG/ML
Dosage Form	INJECTION, SOLUTION
Manufacturer and Country	VETTER PHARMA-FERTIGUNG GMBH AND CO. KG - GERMANY
Registration Number	SIN13216P
Licence Holder	ASTRAZENECA SINGAPORE PTE LTD
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	L02BA03

4.1 Therapeutic indications

FASLODEX is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.

Combination therapy with palbociclib

FASLODEX is indicated in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women with disease progression following endocrine therapy.

Combination therapy with abemaciclib

FASLODEX is indicated in combination with abemaciclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women with disease progression after endocrine therapy.

Combination therapy with ribociclib

FASLODEX is indicated in combination with ribociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in postmenopausal women as initial endocrine based therapy or following disease progression on endocrine therapy.

4.2 Posology and method of administration

Posology

Adult females (including the elderly)

The recommended dose is 500 mg at intervals of one month, with an additional 500 mg dose given two weeks after the initial dose.

Combination therapy with palbociclib

When FASLODEX is used in combination with palbociclib, refer to monotherapy recommended dose instruction for FASLODEX. Refer to the prescribing information for palbociclib for Posology and method of administration.

Prior to the start of treatment with the combination of FASLODEX plus palbociclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.

Combination therapy with abemaciclib

When FASLODEX is used in combination with abemaciclib, refer to monotherapy recommended dose instruction for FASLODEX. Refer to the prescribing information for abemaciclib for Posology and method of administration.

Prior to the start of treatment with the combination of FASLODEX plus abemaciclib, and throughout its duration, pre/perimenopausal women should be treated with LHRH agonists according to local clinical practice.

Combination therapy with ribociclib

When FASLODEX is used in combination with ribociclib, refer to monotherapy recommended dose instruction for FASLODEX. Refer to the prescribing information for ribociclib for Posology and method of administration.

Special population

Paediatric patient:

FASLODEX is not recommended for use in children or adolescents, as safety and efficacy have not been established in this age group.

Renal impairment:

No dose adjustments are recommended for patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min). Safety and efficacy have not been evaluated in patients with severe renal impairment (creatinine clearance < 30 ml/min) and, therefore, caution is recommended in these patients (see Special warnings and precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment:

No dose adjustments are recommended for patients with mild to moderate hepatic impairment. However, as fulvestrant exposure may be increased, FASLODEX should be used with caution in these patients. There are no data in patients with severe hepatic impairment (see Contraindications, Special warnings and precautions for use and Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration

FASLODEX should be administered as two consecutive 5 ml injections by slow intramuscular injection (1–2 minutes/injection), one in each buttock (gluteal area).

Caution should be taken if injecting FASLODEX at the dorsogluteal site due to the proximity of the underlying sciatic nerve.

For detailed instructions for administration, see “Instructions for administration and Special precautions for disposal” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Hypersensitivity to the active substance, or to any of the other excipients.

Pregnancy and lactation (see Pregnancy and lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Severe hepatic impairment (see Special warnings and precautions for use and Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Combination therapy with palbociclib

See palbociclib local Prescribing Information for Contraindications.

Combination therapy with abemaciclib

See abemaciclib local Prescribing Information for Contraindications.

Combination therapy with ribociclib

See ribociclib local Prescribing Information for Contraindications.